4-HYDROXYBUTANOIC ACID Pharmacologic Class Indexing
- Class set ID
- b5ac4323-ac67-4398-bc5f-d83a7e824fe7
- Version
- 3
- Effective date
- 20180813
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use SODIUM OXYBATE ORAL SOLUTION safely and effectively. See full prescribing information for SODIUM OXYBATE ORAL SOLUTION. SODIUM OXYBATE oral solution, CIII Initial U.S. Approval: 2002 | Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 20260421 | 3 |
| These highlights do not include all the information needed to use SODIUM OXYBATE ORAL SOLUTION safely and effectively. See full prescribing information for SODIUM OXYBATE ORAL SOLUTION. SODIUM OXYBATE oral solution, CIII Initial U.S. Approval: 2002 | XLCare Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 20260106 | 2 |
| These highlights do not include all the information needed to use LUMRYZ™ safely and effectively. See full prescribing information for LUMRYZ. LUMRYZ (sodium oxybate) for extended-release oral suspension, CIII Initial U.S. Approval: 2002 | Avadel CNS Pharmaceuticals, LLC | 20251204 | 10 |
| These highlights do not include all the information needed to use XYREM safely and effectively. See full prescribing information for XYREM. XYREM ® (sodium oxybate) oral solution, CIII Initial U.S. Approval: 2002 | Jazz Pharmaceuticals, Inc. | Jazz Pharmaceuticals Ireland Limited | 20250701 | 27 |
| These highlights do not include all the information needed to use XYWAV safely and effectively. See full prescribing information for XYWAV. XYWAV ® (calcium, magnesium, potassium, and sodium oxybates) oral solution, CIII Initial U.S. Approval: 2002 | Jazz Pharmaceuticals, Inc. | Jazz Pharmaceuticals Ireland Limited | 20250701 | 16 |
| These highlights do not include all the information needed to use SODIUM OXYBATE ORAL SOLUTION safely and effectively. See full prescribing information for SODIUM OXYBATE ORAL SOLUTION. SODIUM OXYBATE oral solution, CIII Initial U.S. Approval: 2002 | Amneal Pharmaceuticals LLC | 20250519 | 19 |
| These highlights do not include all the information needed to use SODIUM OXYBATE ORAL SOLUTION safely and effectively. See full prescribing information for SODIUM OXYBATE ORAL SOLUTION . SODIUM OXYBATE oral solution, CIII Initial U.S. Approval: 2002 | Hikma Pharmaceuticals USA Inc. | Jazz Pharmaceuticals, Inc. | Jazz Pharmaceuticals Ireland Limited | 20230425 | 5 |